The Effect of LipoCol Forte® Capsules on the Pharmacokinetics of Nifedipine After Administering Single-dose Combination to Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01346657
• Date of registration: 27/04/2011
• Prospective Registration: No
• Primary sponsor: Taipei Medical University WanFang Hospital
• Public title: The Effect of LipoCol Forte® Capsules on the Pharmacokinetics of Nifedipine After Administering Single-dose Combination to Healthy Subjects
• Scientific title: The Effect of LipoCol Forte® Capsules on the Pharmacokinetics of Nifedipine After Administering Single-dose Combination to Healthy Subjects
• Date of first enrolment: July 2009
• Target sample size: 14
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01346657
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Taiwan

Contacts

• Name: Yuh-Mou Sue, M.D. Ph.D.
• Affiliation: Taipei Medical University WanFang Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subjects must be at the age of 20-40 years old and in good health on the basis of
medical history, physical examination, electrocardiogram, chest X-ray, and routine
laboratory evaluations.

2. Vital signs (after 3 minutes resting in a upright position) which are within the
following ranges:Ear body temperature between 35.0-37.5 degree celsius (°C). Systolic
blood pressure, 90-140 millimeters of mercury (mm Hg). Diastolic blood pressure,
50-90 millimeters of mercury (mm Hg). Pulse rate, 50-90 beats per minute (bpm).
Fasting blood glucose, < 110 milligrams per deciliter (mg/dL).

3. Body weight must be above 50 kilograms (kg) and within -20 to +20% of ideal body
weight.

4. Able to sign informed consent prior to study.

5. Able to communicate well with the investigator and comply with the requirements of
the study.

Exclusion Criteria:

1. Use of any prescription medication within 14 days prior to dosing.

2. Use of over-the-counter medications or vitamins within 14 days prior to dosing.

3. Significant illness within 2 weeks prior to dosing.

4. Participation in any clinical investigation within 2 months prior to dosing or longer
than required by local regulation.

5. Donate or loss more than 500 milliliter(mL) of blood within 3 months prior to dosing.

6. Presence of cardiovascular disease.

7. Presence of gastrointestinal disease.

8. Presence of asthma or lung disease.

9. Presence of liver disease, hepatitis B, hepatitis C or liver injury as indicated by
an abnormal liver function profile.

10. Presence of impaired renal function.

11. Presence of neurological disease.

12. Presence of psychiatrical disease.

13. Subject is known for HIV infected.

14. A known hypersensitivity to nifedipine, lovastatin and Chinese Red Yeast Rice or
their analogs.

15. History of drug or alcohol abuse within 12 months prior to dosing.

16. Permanent confinement to an institution.

17. Individuals are judged by the investigator or pharmacokineticist to be undesirable as
subjects for other reasons.



Age minimum: 20 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Drug: Nifidipine & LipoCol

Primary Outcome(s)

Evaluation of the pharmacokinetic parameters of nifedipine in healthy subjects [Time Frame: 1 week]

Secondary Outcome(s)

The incidence rate of adverse event [Time Frame: 1 week]

Secondary ID(s)

98030

Source(s) of Monetary Support

Please refer to primary and secondary sponsors